{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-219365","form_type":"8-K","ticker":"GUTS","cik":"0001572616","company_name":"FRACTYL HEALTH, INC.","filed_at":"2026-05-12T20:05:16+00:00","discovered_at":"2026-05-12T20:06:00.295312+00:00","generated_at":"2026-05-12T21:36:23.138315+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Fractyl Health Q1 net income $9.2M on non-cash warrant change; Revita pivotal data on track for early Q4","bullets":["Q1 R&D expenses $15.6M (down from $19.4M YoY); SG&A $5.2M; adjusted EBITDA -$18.0M.","Cash $63.2M; runway into early 2027, beyond anticipated pivotal data readout.","Revita REMAIN-1 Pivotal topline 6-month data expected early Q4 2026; FDA De Novo submission target late Q4 2026.","1-year REVEAL-1 Cohort data in Q2 2026; 1-year randomized REMAIN-1 Midpoint data in Q3 2026.","RJVA-001 first-in-human dosing and preliminary data expected in H2 2026 after Netherlands CTA authorization."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-219365","json":"https://secwatch.observer/filing/0001193125-26-219365.json","markdown":"https://secwatch.observer/filing/0001193125-26-219365.md","text":"https://secwatch.observer/filing/0001193125-26-219365.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526219365/0001193125-26-219365-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526219365/guts-20260512.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T21:36:23.138315+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"ffa53bb909198fa1cba785086bfbe68deaa1b748","claim":"FRACTYL HEALTH, INC. reported the quarter ended March 31, 2026 results: net income $9.2 million. Guidance reaffirmed.","evidence_excerpt":"Fractyl Health, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2026","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1572616/000119312526219365/0001193125-26-219365-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the quarter ended March 31, 2026"},{"label":"Net income","value":"$9.2 million"},{"label":"Guidance","value":"reaffirmed"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}